Chronic kidney disease (CKD) is a growing public health issue worldwide. In Italy, the prevalence of CKD is 7.5% in men and 6.5% in women . In Italy, the annual direct costs of management for patients on dialysis were estimated to be around €30,000 for peritoneal dialysis and €44,000 for haemodialysis . Erythropoiesis-stimulating agents (ESAs) have a significant economic burden in CKD as they are widely used to treat CKD-related anaemia; biosimilars can guarantee a 20%–30% saving on ESA purchase costs in CKD patients .
A multicentre, cohort study  aimed to investigate the direct healthcare costs of CKD patients treated with ESAs and the potential savings achievable by increasing the use of biosimilars and preventing inappropriate ESA use.
This population-based study was conducted using the claims databases of Tuscany, Umbria Regions and Caserta, Treviso, Palermo Local Health Units (LHUs), covering a total population of around eight million people (13.2% of the total Italian population) during the years 2009–2014. For the Umbria region, the available observation period was from 2011 to 2014. From the source population, patients were included in the study if they met all the following criteria: a) had at least two ESA pharmacy claims during the study period (first pharmacy claim: Index date, ID) separated by < 365 days and no ESA pharmacy claims within one year prior to ID, i.e. incident ESA users; b) had at least 365 days pre- and post-index continuous enrolment in their database; c) had at least one medical claim with a diagnosis of CKD any time prior to ID, including the ID. Finally, among incident ESA users with CKD, all patients with known CKD stage were identified. Incident ESA users with CKD included in the study cohort were described at baseline in terms of demographic and clinical characteristics, number of hospitalizations, concomitant drugs and CKD stage, i.e. stage I-III, stage IV-V and dialysis. All analyses were stratified by type of ESA dispensed at ID. Yearly mean direct healthcare costs per patient were estimated, stratifying by CKD stage. The total yearly cost and potential savings related to ESA use were estimated: a) considering 25%/50%/75% of originator ESA substitution with biosimilars; b) eliminating inappropriate ESA dispensing.
During the study period, on a total population of 7,939,874 subjects registered in the five study centres, 7,810 (0.1%) incident ESA users with CKD were treated for at least 1 year (reference product: 1,139, 14.6%; biosimilars: 1,204, 15.4%; other originator ESAs: 5,467, 70.0%). For 2,921 (37.4%) of these incident ESA users, information on CKD stage was available. There were no statistically significant age and sex differences across incident users of different ESA types. The ESA-related yearly mean cost represented 17% of total yearly costs in stage I-III, decreasing to 13% in stage IV-V and 6% in dialysis. Among originator users, assuming 25% biosimilar uptake, the annual cost-savings of ESA treatment would amount to €161,417 (10.0% of total ESA costs) in CKD stage I-III, €112,512 (10.9%) in CKD stage IV-V and €136,972 (7.7%) in dialysis. Assuming 50% or 75% substitution of originator with biosimilar ESA, these cost-savings would increase up to 15%–30% of total ESA costs. Among incident ESA users for which haemoglobin levels were available, 9% started inappropriate ESA treatment, increasing to 62.0% during the first year of maintenance therapy. Hypothesizing prevention of the first inappropriate ESA dispensing, the total yearly cost-savings would amount to €35,772, increasing to €167,641 when all inappropriate dispensing during maintenance therapy was removed.
The authors concluded that a high cost of CKD management among dialysis patients was observed in this study as it was elsewhere, but an unexpected level of inappropriate ESA use contributed more than €165,000 in preventable costs per year. The use of biosimilars was observed in 15% of new ESA users with CKD treated for at least 1 year, while the remainder used originator ESAs. With a higher use of biosimilar ESAs the annual cost-savings would range from 8% to 30% of the total ESA costs. Higher use of the lowest cost ESA and prevention of inappropriate ESA use, as well as other strategies aimed at slowing down progressive renal impairment, are essential for minimizing the clinical and economic burden of CKD.
Conflict of interest
The author of the paper  reported that the study was conducted in the context of the ‘Assessment of short- and long-term risk-benefit profile of biologics through healthcare database network in Italy’ project, which was funded by Italian Ministry of Health.
Abstracted by Ylenia Ingrasciotta, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Italy.
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